Insulin Use and Respiratory Muscle Strength in Type 2 Diabetes

January 26, 2026 updated by: AYŞE KAYALI VATANSEVER, Izmir Bakircay University

Respiratory Muscle Strength, Pulmonary Function, and Post-Exercise Recovery Responses According to Insulin Use in Individuals With Type 2 Diabetes Mellitus

This study compares breathing function, breathing muscle strength, and recovery after a walking test in adults with type 2 diabetes, based on whether they use insulin.

People with type 2 diabetes will be evaluated during a single study visit at Izmir Bakircay University. Participants will be grouped as either currently using insulin or not using insulin as part of their usual diabetes treatment. All participants will complete the same tests: a breathing test (spirometry), breathing muscle strength tests (maximal inspiratory and expiratory pressures), and a 6-minute walk test.

Before the walk test, immediately after the test, and 5 minutes after the test, recovery measures such as heart rate, oxygen saturation, blood pressure, and perceived shortness of breath and fatigue will be recorded. The goal is to understand whether insulin use is associated with differences in breathing and recovery responses in people with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İzmir
      • Izmir, İzmir, Turkey (Türkiye), 35353
        • Bakircay University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 40-70 years with a diagnosis of type 2 diabetes mellitus who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Research and Practice Center and met the eligibility criteria. Participants were categorized as insulin-treated or non-insulin-treated based on current usual care.

Description

Inclusion Criteria:

  • Age 40 to 70 years
  • Diagnosis of type 2 diabetes mellitus for at least 1 year
  • Receiving diabetes treatment (oral antidiabetic agents and/or insulin) for at least 6 months
  • Stable metabolic status (HbA1c ≤ 10%)
  • Independent ambulation
  • Able to read and understand Turkish
  • Provided written informed consent

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus
  • Active diabetic foot ulcer
  • Acute respiratory tract infection or known chronic respiratory disease (e.g., COPD, asthma, interstitial lung disease)
  • Cardiovascular disease history that may limit exercise testing (e.g., heart failure, uncontrolled hypertension, arrhythmia)
  • Neurological disease, musculoskeletal problem, or balance disorder precluding participation in the exercise test
  • Major surgery within the past 6 months
  • Current cancer treatment or history of malignancy
  • Cognitive impairment or psychiatric condition limiting cooperation
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Insulin-Treated Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus who are currently using insulin therapy as part of usual care at the time of assessment.
Non-Insulin-Treated Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus who are not using insulin therapy as part of usual care at the time of assessment (e.g., lifestyle and/or oral antidiabetic agents).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Inspiratory Pressure (MIP)
Time Frame: Single Visit (Baseline)
Maximal inspiratory pressure (cmH2O) assessed using a respiratory pressure meter according to standardized respiratory muscle strength testing procedures. The best value from repeated acceptable maneuvers will be used for analysis.
Single Visit (Baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Expiratory Pressure (MEP)
Time Frame: single Visit (Baseline)
Maximal expiratory pressure (cmH2O) assessed using a respiratory pressure meter. The best value from repeated acceptable maneuvers will be used.
single Visit (Baseline)
Spirometry Parameters (FVC) Forced Vital Capacity
Time Frame: Single Visit (Baseline)
Pulmonary function measured by spirometry following standard procedures.
Single Visit (Baseline)
6-Minute Walk Distance (6MWD)
Time Frame: Single Visit (During 6-Minute Walk Test)
Total distance walked in 6 minutes (meters) on a standardized 30-meter corridor using standardized instructions.
Single Visit (During 6-Minute Walk Test)
Heart Rate Response and Recovery After the 6-Minute Walk Test
Time Frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Heart rate (beats/min) recorded at the specified time points using pulse oximetry.
Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Oxygen Saturation (SpO₂) Response and Recovery After the 6-Minute Walk Test
Time Frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Peripheral oxygen saturation (SpO₂, %) recorded at the specified time points using pulse oximetry.
Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Blood Pressure Response and Recovery After the 6-Minute Walk Test
Time Frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Systolic and diastolic blood pressure (mmHg) measured in a seated position at the specified time points.
Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Single Visit (Baseline)
Pulmonary function measured by spirometry following standard procedures.
Single Visit (Baseline)
FEV1/FVC Ratio
Time Frame: Single Visit (Baseline)
Calculated from spirometry values following standard procedures.
Single Visit (Baseline)
Peak Expiratory Flow (PEF)
Time Frame: Single Visit (Baseline)
Pulmonary function measured by spirometry following standard procedures.
Single Visit (Baseline)
Rating of Perceived Dyspnea During Recovery (Modified Borg Dyspnea Scale, 0-10)
Time Frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Perceived dyspnea will be assessed using the Modified Borg Dyspnea Scale (0 = no breathlessness at all; 10 = maximal breathlessness). Higher scores indicate worse dyspnea.
Pre-Test; Immediately Post-Test; 5 Minutes Post-Test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Bakircay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data will not be shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe